US Federal regulators on Monday approved GlaxoSmithKline's antidepressant Wellbutrin XL to help treat the estimated half a million people in the United States who suffer from winter depression.
The US Food and Drug Administration said the drug is the first to be approved to treat the condition, which causes bouts of recurrent depression, and is known as seasonal affective disorder, or SAD. Wellbutrin XL (bupropion HCL extended release tablets) had been previously approved for treatment of major depressive disorder.
"The effectiveness of Wellbutrin XL for the prevention of SAD episodes was established in 3 double-blind, placebo-controlled trials in adults with a history of major depressive disorder in autumn and winter," the FDA said in a prepared statement. "Treatment was initiated prior to the onset of symptoms in the autumn (September to November) and was discontinued following a two-week taper that began the first week of spring (fourth week of March). In these trials, the percentage of patients who were depression-free at the end of treatment was significantly higher for those on Wellbutrin XL than for those on placebo; for all 3 studies combined, the overall rate of patients depression-free at the end of treatment was 84 percent for those on Wellbutrin XL compared to 72 percent for those on placebo."
The drug's label includes a "black box" warning on the increased risk of suicidal thoughts and behaviour in paediatric patients treated with antidepressants.
As sunlight patterns change in autumn and winter, there is a shift in the "biological internal clocks" or circadian rhythms, according to the National Mental Health Association. This can cause your biological clock to be out of step with normal activities. January and February are the most difficult months for sufferers, and younger persons and women are at higher risk, the association says. – (HealthDayNews)